Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on ELISA assays and GC/MS confirmation, which are standard laboratory techniques and do not indicate the use of AI or ML. The "Mentions AI, DNN, or ML" section is explicitly marked as "Not Found".

Therapeutic

No
This device is an in vitro diagnostic test intended for the qualitative detection of specific substances in human hair for drug screening, not for treatment or therapy.

Diagnostic

Yes
The device is described as an "in vitro diagnostic test" and its intended use is for the "qualitative detection of opiates… and oxycodone and hydrocodone… in human head and body hair" to confirm screen positive results, which are both characteristics of a diagnostic device.

SaMD (Software as a Medical Device)

No

The device description explicitly states it is a "test system" utilizing "ELISA assays," which are laboratory-based biochemical tests involving physical reagents and equipment, not solely software.

IVD (In Vitro Diagnostic)

Yes, this device is an IVD (In Vitro Diagnostic).

Here's why:

Explicitly Stated in Intended Use: The very first sentence of the "Intended Use / Indications for Use" section clearly states: "The Omega Laboratories Hair Drug Screening Assay (Opiates, Oxycodone and Hydrocodone) is an in vitro diagnostic test..."
Analyzes Human Specimens: The device is intended for use with "human head and body hair," which are human specimens.
Provides Diagnostic Information: The test is used for the "qualitative detection of opiates... and oxycodone and hydrocodone" in these specimens, providing information about the presence of these substances in the individual. This information is used to screen for drug use, which is a diagnostic purpose.
Performed In Vitro: The analysis of the hair sample is performed outside of the human body, in a laboratory setting, which is the definition of "in vitro."

The rest of the document further supports this by describing the laboratory-based ELISA assay, the need for confirmation with other analytical methods, and the performance studies conducted to validate the test's ability to detect the target substances in hair samples.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The Omega Laboratories Hair Drug Screening Assay (Opiates, Oxycodone and Hydrocodone) is an in vitro diagnostic test that is intended for the qualitative detection of opiates (calibrated with morphine) and oxycodone and hydrocodone (calibrated with oxycodone) at or above 300 pg/mg in human head and body hair. To confirm a screen positive result. a more specific alternate chemical method, such as Gas ChromatographyMass Spectrometry (GC/MS) operating in the selected ion monitoring (SIM) mode is the preferred method with deuterated internal standards. Professional judgment should be applied to any drug of abuse test result, particularly when presumptive positive results are obtained. This test is intended exclusively for single laboratory use only and is not intended for sale to anyone.

Product codes (comma separated list FDA assigned to the subject device)

DJG

Device Description

Not Found

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

human head and body hair

Indicated Patient Age Range

Not Found

Intended User / Care Setting

single laboratory use only

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Specificity: The Cross-reactivity study was designed to evaluate the specificity of the Omega Laboratories, Inc. ELISA Screening Protocol and the possible effect of interfering compounds. Negative hair extracts were spiked with morphine or oxycodone at -50% (125pg/mg), +125% (375pg/mg) and +150% (450pg/mg) of the Cutoff Concentration (300pg/mg). These were then additionally spiked with 10000ng/ml (400000pg/mg) of the structurally related compounds unless otherwise noted. The absorbances were compared to the 300 pg/mg Cutoff control (CO). The analysis was performed in triplicate.

Agreement Studies:
Opiates: 226 head and body hair samples (176 head hair samples in Study 1 and 50 body hair samples in Study 3).
Oxycodone and Hydrocodone: 530 head and body hair samples (240 head hair samples in Study 1, 240 head hairs samples in retrospective analysis Study 2 and 50 body hair samples in Study 3).
In the studies, each specimen was divided into two aliquots and one was used for screening and the other for GC/MS confirmation. Testing was performed on body and head hair samples from different ages, gender, ethnicities and hair color.

Stability: Hair samples previously confirmed positive were stored in the Omega Collection Kit (poly transport bag, foil, specimen pouch/envelope). The hair was tested for an average of 3.1 years for opiate samples and approximately 2 years for oxycodone and hydrocodone samples. 54 samples varying in ethnic origin, hair color, and curvature were tested.

Shipping: 260 head hair samples (155 previously confirmed positive, 100 previously screened negative, and 5 confirmed below 300 pg/mg cutoff). Each box contained a variety of hair color and curvature. Negative samples were shipped separate from positive samples. Shipping temperatures and humidity ranges were recorded for samples.

Cosmetic Treatment: 176 hair samples were used in this study. Of these, 176 were identified as positive for opiates and/or oxycodone by ELISA assays in the untreated run, and 64 were identified as negative by ELISA assay. The ethnic origin, hair color, and curvature were documented. Each specimen was divided into 2 aliquots. One aliquot was analyzed by the ELISA protocol and GC/MS confirmation method. The second aliquots were randomly assigned to hair treatments (bleach, perm, dye, relaxer, shampoo) and treatments were performed following the product insert. Treated aliquots were analyzed by the ELISA protocol and GC/MS confirmation method.

Environmental Contamination: Two studies were performed. In the first study, drug-free hair was exposed to Opiates, Oxycodone, and Hydrocodone, then washed with methanol three times. Confirmation testing was performed on the samples and the washes. The second study involved performing confirmation testing on known positive samples and observing whether methanol washes changed the final result. Head hair was used for this study.

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

PRECISION:
Intra-assay precision studies: 11 replicates of negative head hair samples spiked to various concentrations (zero drug, -75%, -50%, -25% below cutoff, and +25%, +50%, +75% and +100% above cutoff). All samples treated and analyzed as donor hair samples in one run.
Inter-assay precision studies: Negative hair samples spiked to various concentrations (zero drug, -75%, -25% below cutoff, and +25%, +50%, +75% and +100% above cutoff). 11 replicates prepared and analyzed over 20 non-consecutive days.
Key results: All samples behaved as expected across the tested concentrations for both intra-assay and inter-assay precision.

AGREEMENT STUDIES:
Study type: Method comparison.
Sample size: Opiates: 226 head and body hair samples. Oxycodone and Hydrocodone: 530 head and body hair samples.
Key results: Substantial agreement with predicate device.
Opiates Agreement Studies (n=226): 116 High Positive, 24 Near Cutoff Positive, 2 Near Cutoff Negative, 4 Less than half the cutoff concentration, 70 Negative.
Oxycodone and Hydrocodone Agreement Studies (n=483* from 530 initial samples): 221 High Positive, 94 Near Cutoff Positive, 6 Near Cutoff Negative, 6 Less than half the cutoff concentration, 140 Negative. Note: 46 ELISA positive head hair samples were negative by GC/MS for oxycodone but positive for hydrocodone, and one head hair test sample was lost.
Hydrocodone Agreement Studies (n=500 from 530 initial samples): 201 High Positive, 110 Near Cutoff Positive, 8 Near Cutoff Negative, 8 Less than half the cutoff concentration, 142 Negative. *Note: 27 ELISA positive head hair samples were negative by GC/MS for hydrocodone but positive for oxycodone, one head hair test sample was lost, and 2 ELISA head hair positive samples were not able to be confirmed by GC/MS.

CROSS-REACTIVITY:
Study type: Evaluation of specificity and interfering compounds.
Key results: Only compounds that were structurally cross-reactive interfered in the assay. No tested samples produced a negative result when expected to be positive. Re-evaluation with extended concentration ranges showed cross-reactivity for Buprenorphine, Noroxymorphone, 3-Methoxynaltrexone, Morphine-6-beta-glucuronide, Nalmefene, Nalorphine, Naloxone-3-beta-D-glucuronide, and Naltriben.

CALIBRATOR AND CONTROL:
Study type: Validation and stability of in-house prepared calibrators and control solutions.
Key results: Successfully demonstrated validation and stability, and traceability to NIST standards. Morphine and oxycodone in methanol were stable for one year, within 10% of target value, validating the 1-year expiration date for the calibrator stock solution.

STABILITY:
Study type: Storage stability.
Sample size: 54 previously confirmed positive hair samples.
Key results: Opiates are stable in hair for 3 years, and oxycodone and hydrocodone are stable for 2 years when stored in the Omega Collection Kit.

SHIPPING:
Study type: Impact of shipping conditions on hair samples.
Sample size: 260 head hair samples.
Key results: No adverse effect on hair samples that would affect the screening assay when exposed to extreme temperatures and variations in humidity during sample transport. The average mean % of change in screening result prior to and after shipping was 1.9%. Four out of 260 samples showed different screening results, all within ±50% (150-450 pg/mg) of the cutoff level.

COSMETIC TREATMENT:
Study type: Effect of cosmetic treatments on drug and metabolite detection.
Sample size: 176 hair samples.
Key results: Cosmetic treatments can reduce the amount of drugs detectable. No single treatment had a more defined effect. The largest change was observed for oxycodone with relaxer (-34.8%). Bleach treatment appeared to have consistent results across all drugs. All treatments appeared to have the greatest change on oxycodone. Some changes in ELISA assay test results (Positive to Negative or Negative to Positive) were observed, especially for Dye and Permanent treatments.

ENVIRONMENTAL CONTAMINATION:
Study type: Distinguishing true analytically positive samples from externally exposed samples via methanol wash.
Key results: The methanol wash procedure effectively mitigated the risk of false positive results while maintaining true analytical positive results. All analytically negative samples remained negative after exposure and wash. All clinically positive samples remained positive after wash steps.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

Omega Hair Drug Screening Assay for Opiates, Oxycodone and Hydrocodone (K103161)

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

Regulation Number and Section

§ 862.3650 Opiate test system.

(a)
Identification. An opiate test system is a device intended to measure any of the addictive narcotic pain-relieving opiate drugs in blood, serum, urine, gastric contents, and saliva. An opiate is any natural or synthetic drug that has morphine-like pharmocological actions. The opiates include drugs such as morphine, morphine glucoronide, heroin, codeine, nalorphine, and meperedine. Measurements obtained by this device are used in the diagnosis and treatment of opiate use or overdose and in monitoring the levels of opiate administration to ensure appropriate therapy.(b)
Classification. Class II (special controls). An opiate test system is not exempt if it is intended for any use other than employment or insurance testing or is intended for Federal drug testing programs. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9, provided the test system is intended for employment and insurance testing and includes a statement in the labeling that the device is intended solely for use in employment and insurance testing, and does not include devices intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military).

Summary

0

Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is an abstract image of an eagle.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

January 8, 2015

OMEGA LABORATORIES, INC. ROBERT BARD MANAGING DIRECTOR 400 NORTH CLEVELAND MOGADORE OH 44260

Re: K140671

Trade/Device Name: Omega Laboratories Hair Drug Screening Assay, (Opiates, Oxycodone and Hydrocodone)

Regulation Number: 21 CFR 862.3650 Regulation Name: Opiate test system Regulatory Class: II Product Code: DJG Dated: January 5, 2015 Received: January 6, 2015

Dear Mr. Robert Bard:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

1

If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Stayce Beck -S

For : Courtney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

2

Indications for Use

510(k) Number (if known) K140671

Device Name

Omega Laboratories Inc. Hair Drug Screening Assay (Opiates, Oxycodone and Hydrocodone)

Indications for Use (Describe)

The Omega Laboratories Hair Drug Screening Assay (Opiates, Oxycodone and Hydrocodone) is an in vitro diagnostic test that is intended for the qualitative detection of opiates (calibrated with morphine) and oxycodone and hydrocodone (calibrated with oxycodone) at or above 300 pg/mg in human head and body hair. To confirm a screen positive result. a more specific alternate chemical method, such as Gas ChromatographyMass Spectrometry (GC/MS) operating in the selected ion monitoring (SIM) mode is the preferred method with deuterated internal standards. Professional judgment should be applied to any drug of abuse test result, particularly when presumptive positive results are obtained.

This test is intended exclusively for single laboratory use only and is not intended for sale to anyone.

Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

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Page 1 of 33

510(k) SUMMARY

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92

510(k) Number:	K140671
Date of Summary:	January 5, 2015
Applicant:	William R. Corl
Chief Executive Officer
Omega Laboratories, Inc.
400 North Cleveland
Mogadore, OH 44260
Tel: 330-628-5748
Fax: 330-628-5803
Correspondent:
Name:	ROBERT J BARD, JD, CQE, RAC
Address:	Omega Laboratories
400 North Cleveland, Mogadore, OH 44260
Phone Number:	248-573-5040
E-mail	rbard@reglaw.net
Product Name:
Trade Name:	Omega Laboratories Inc. Hair Drug Screening Assay (Opiates, Oxycodone and Hydrocodone)
Common Name:	Hair Drug Screening Assay Opiates
Regulation Number:	CFR 862.3650 (ProCode DJG)
Classification Name:	Opiate test system.
Classification Panel:	91 (Toxicology)
Predicate Device:	Omega Hair Drug Screening Assay for Opiates, Oxycodone and Hydrocodone (K103161)
Indication for Use:	The Omega Laboratories Hair Drug Screening Assay (Opiates, Oxycodone and Hydrocodone) is an in vitro diagnostic test that is intended for the qualitative detection of opiates (calibrated with morphine) and oxycodone and hydrocodone (calibrated with oxycodone) at or above 300 pg/mg in human head and body hair. To confirm a screen positive result, a more specific alternate chemica method, such as Gas Chromatography/Mass Spectrometry (GC/MS) operating in the selected ion monitoring (SIM) mode is the preferrec method with deuterated internal standards. Professional judgment should be applied to any drug of abuse test result, particularly when presumptive positive results are obtained.
This test is intended exclusively for single laboratory use only and is not intended for sale to anyone
Comparison:	When used to qualitatively detect Opiates, Oxycodone and
Hydrocodone in head and body hair specimens collected with the
Omega Specimen Collection Device, the Omega assays yield results in
substantial agreement with the predicate device (see Table 1 below).
Comparison Performance
Data:	All performance studies demonstrated that the Omega assay is in
substantial agreement with the predicate products.
Results obtained from donor specimens showed that the qualitative
results from the new assays are substantially equivalent to those
obtained from the predicate devices.

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Page 2 of 33

Table 1: Comparison of Omega Hair Drug Screening Assay for Opiates, Oxycodone and Hydrocodone

| Comparison
Element -
Similarities | Hair Drug Screening Assay for Opiates,
Oxycodone and Hydrocodone. (Subject
devices K140671) | Hair Drug Screening Assay Opiates,
Oxycodone and Hydrocodone (Predicate
device K103161) |
|-----------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Laboratory | Omega Laboratories, Inc. | Same. |
| Indication for/
Intended Use | The Omega Laboratories Hair Drug
Screening Assay (Opiates, Oxycodone
and Hydrocodone) is an in vitro
diagnostic test that is intended for the
qualitative detection of opiates (calibrated
with morphine) and oxycodone and
hydrocodone (calibrated with oxycodone)
at or above 300 pg/mg in human head
and body hair. To confirm a screen
positive result, a more specific alternate
chemical method, such as Gas
Chromatography/Mass Spectrometry
(GC/MS) operating in the selected ion
monitoring (SIM) mode is the preferred
method with deuterated internal standards.
Professional judgment should be applied
to any drug of abuse test result,
particularly when presumptive positive
results are obtained.
This test is intended exclusively for single
laboratory use only and is not intended for
sale to anyone. | The Omega Laboratories Hair Drug
Screening Assays are test systems that
utilize ELISA assays for the qualitative
detection of morphine and related opiates
(calibrated with morphine) and oxycodone
and hydrocodone (calibrated with
oxycodone) at or above 300 pg/mg in head
hair samples.
The Omega Laboratories Hair Drug
Screening Assay for Opiates, Oxycodone
and Hydrocodone provide only preliminary
analytical test results. A more specific
alternate chemical method must be used in
order to obtain a confirmed result. Gas
Chromatograph - Mass Spectrometry
operating in the selected ion monitoring
(SIM) mode or GC/MS/MS in selected
reaction mode (SRM) is the preferred
method with deuterated internal standards. |
| Method of
Measurement | Microplate reader. Read at 450 nm | Same. |
| Matrix | Head and body hair | Head hair |
| Cutoff
concentration | 300 pg Opiates, Oxycodone and Hydrocodone
/mg hair | Same. |
| Assay Principal | ELISA | Same. |

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Page 3 of 33

Table 1: Comparison of Omega Hair Drug Screening Assay for Opiates, Oxycodone and Hydrocodone

| Comparison
Element -
Similarities | Hair Drug Screening Assay for Opiates,
Oxycodone and Hydrocodone. (Subject
devices K140671) | Hair Drug Screening Assay Opiates,
Oxycodone and Hydrocodone (Predicate
device K103161) |
|-----------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------|
| Extraction
Method | Utilized acid-methanol vs. methanol alone
to facilitate extraction of drug from hair.
Proprietary and patent pending method of
pulverizing hair vs. cutting the hair into
small segments prior to acid-methanol
extraction. This improved extraction times
without loss of efficiency | Same. |

Performance Studies

PRECISION :

Intra-assay precision studies were performed using 11 replicates of negative head hair samples spiked to the following concentrations of opiates, oxycodone; and hydrocodone: zero drug, -75%, -50%, -25% below the cutoff, and +25%, +50%, +75% and+100% above the cutoff. All samples were treated and analyzed in the same manner as donor hair samples and measured in one run. Head hair was used in this study.

| Drug | Concentration of
Sample (pg/mg) | Number of
Replicates | Results #
Negative | Results #
Positive |
|-----------|------------------------------------|-------------------------|-----------------------|-----------------------|
| Opiates | 0 | 11 | 11 | 0 |
| Opiates | 75 | 11 | 11 | 0 |
| Opiates | 150 | 11 | 11 | 0 |
| Opiates | 225 | 11 | 11 | 0 |
| Opiates | 375 | 11 | 0 | 11 |
| Opiates | 450 | 11 | 0 | 11 |
| Opiates | 525 | 11 | 0 | 11 |
| Opiates | 600 | 11 | 0 | 11 |
| Oxycodone | 0 | 11 | 11 | 0 |
| Oxycodone | 75 | 11 | 11 | 0 |
| Oxycodone | 150 | 11 | 11 | 0 |
| Oxycodone | 225 | 11 | 11 | 0 |
| Oxycodone | 375 | 11 | 0 | 11 |
| Oxycodone | 450 | 11 | 0 | 11 |
| Oxycodone | 525 | 11 | 0 | 11 |
| Oxycodone | 600 | 11 | 0 | 11 |

Table 2: Intra-Assay Precision Studies (opiates, oxycodone and hydrocodone)

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Page 4 of 33

| Drug | Concentration of
Sample (pg/mg) | Number of
Replicates | Results #
Negative | Results #
Positive |
|-------------|------------------------------------|-------------------------|-----------------------|-----------------------|
| Hydrocodone | 0 | 10 | 10 | 0 |
| Hydrocodone | 75 | 10 | 10 | 0 |
| Hydrocodone | 150 | 10 | 10 | 0 |
| Hydrocodone | 225 | 10 | 9 | 1 |
| Hydrocodone | 375 | 10 | 0 | 10 |
| Hydrocodone | 450 | 10 | 0 | 10 |
| Hydrocodone | 525 | 10 | 0 | 10 |
| Hydrocodone | 600 | 10 | 0 | 10 |

Table 2: Intra-Assay Precision Studies (opiates, oxycodone and hydrocodone)

Inter-assay precision studies were performed using negative hair samples spiked to the following concentrations of opiates, oxycodone and hydrocodone: zero drug, -75%, -25% below the cutoff, and +25%, +50%, +75% and+100% above the cutoff.

All samples were treated and analyzed in the same manner as donor hair samples, which is summarized in Section 9.0. Eleven replicates of these were prepared and analyzed over 20 non-consecutive days. The results of this study are summarized in the tables below and the raw data is attached.

Tables 15a through 15c summarize the result of the Opiates, Oxycodone and Hydrocodone Inter-Assay Precision testing of the Omega Laboratories Drug Screening in Hair Assays.

| Drug | Conc. (pg/mg)
(% of Cutoff) | Number
Tested | Negative | Positive |
|---------|--------------------------------|------------------|----------|----------|
| Opiates | 0 (Negative) | 220 | 220 | 0 |
| Opiates | 75 (-75) | 220 | 220 | 0 |
| Opiates | 150 (-50) | 220 | 220 | 0 |
| Opiates | 225 (-25) | 220 | 220 | 0 |
| Opiates | 375 (125) | 220 | 0 | 220 |
| Opiates | 450 (150) | 220 | 0 | 220 |
| Opiates | 525 (175) | 220 | 0 | 220 |
| Opiates | 600 (200) | 220 | 0 | 220 |

Table 3a: Inter-assay Opiates Precision Study Summary (non-normalized)

Table 3b: Inter-assay Oxycodone Precision Study Summary (non-normalized)

| Drug | Conc. (pg/mg)
(% of Cutoff) | Number
Tested | Negative | Positive |
|-----------|--------------------------------|------------------|----------|----------|
| Oxycodone | 0 (Negative) | 220 | 220 | 0 |
| Oxycodone | 75 (-75) | 220 | 220 | 0 |
| Oxycodone | 150 (-50) | 220 | 220 | 0 |
| Oxycodone | 225 (-25) | 220 | 220 | 0 |

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Page 5 of 33

| Drug | Conc. (pg/mg)
(% of Cutoff) | Number
Tested | Negative | Positive |
|-----------|--------------------------------|------------------|----------|----------|
| Oxycodone | 375 (125) | 220 | 0 | 220 |
| Oxycodone | 450 (150) | 220 | 0 | 220 |
| Oxycodone | 525 (175) | 220 | 0 | 220 |
| Oxycodone | 600 (200) | 220 | 0 | 220 |

Table 3c: Inter-assay Hydrocodone Precision Study Summary (non-normalized

| Drug | Conc. (pg/mg)
% of Cutoff | Number
Tested | Negative | Positive |
|-------------|------------------------------|------------------|----------|----------|
| Hydrocodone | 0 (Negative) | 100 | 100 | 0 |
| Hydrocodone | 75 (-75) | 100 | 100 | 0 |
| Hydrocodone | 150 (-50) | 100 | 100 | 0 |
| Hydrocodone | 225 (-25) | 100 | 61 | 39 |
| Hydrocodone | 375 (125) | 100 | 0 | 100 |
| Hydrocodone | 450 (150) | 100 | 0 | 100 |
| Hydrocodone | 525 (175) | 100 | 0 | 100 |
| Hydrocodone | 600 (200) | 100 | 0 | 100 |

AGREEMENT STUDIES:

The method comparison was performed using two opiates studies by testing 226 head and body hair samples consisting of 176 head hair samples in Study 1 and 50 body hair samples in Study 3.

Agreement studies also included 530 head and body hair samples that were tested in three oxycodone and hydrocodone studies consisting of 240 head hair samples in Study 1, 240 head hairs samples in retrospective analysis Study 2 and 50 body hair samples in Study 3.

In the studies, each specimen was divided into two aliquots and one was used for screening and the other for GC/MS confirmation. Testing was performed on body and head hair samples from different ages, gender, ethnicities and hair color. The results were:

Opiates Agreement Studies (from Studies 1 and 3)

		Table 3a: Opiates Equivalents Summary of Agreement Study Results (n=226) Head and Body
--	--	----------------------------------------------------------------------------------------

| ELISA Test
Result | Negative by
GC/MS | Less than half
the cutoff
concentration
by GC/MS | Near Cutoff
Negative
(Between 50%
below the
cutoff and the
cutoff
concentration) | Near Cutoff
Positive
(Between the
cutoff and 50%
above the cutoff
concentration) | High Positive
(Greater that
50% above the
cutoff
concentration) |
|----------------------|----------------------|-----------------------------------------------------------|----------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------|
| Positive | 0 | 0 | 2 | 24 | 116 |
| Negative | 70 | 4 | 9 | 1 | 0 |

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Page 6 of 33

| Sample
No. | Screening Cutoff
(pg/mg) | ELISA Test
Result
(POS/NEG) | GC/MS Cutoff
(pg/mg) | GC/MS Drug Result (pg/mg) |
|---------------|-----------------------------|-----------------------------------|-------------------------|---------------------------|
| 16 | 300 | POS | 300 | HDC 268 |
| 150 | 300 | POS | 300 | HDC 299 |
| 29 | 300 | NEG | 300 | HDC 354 |

Table 3b: GC/MS Summary of Opiates Equivalents Discordant Results

Oxycodone and Hydrocodone Agreement Studies (from Studies 1,2 and 3)

| ELISA
Test
Result | Negative by
GC/MS | Less than half
the cutoff
concentration
by GC/MS | Near Cutoff
Negative
(Between 50%
below the
cutoff and the
cutoff
concentration) | Near Cutoff
Positive
(Between the
cutoff and 50%
above the cutoff
concentration) | High Positive
(Greater that
50% above
the cutoff
concentration) |
|-------------------------|----------------------|-----------------------------------------------------------|----------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------|
| Positive | 0 | 0 | 6 | 94 | 221 |
| Negative | 140 | 6 | 14 | 2 | 0 |

*Of the 530 samples compared in the Oxy assays, 46 ELISA positive head hair samples were negative by GC/MS confirmation for oxycodone but positive for hydrocodone and one head hair test sample was lost during centrifugation reducing the number of test samples reported here to 483.

		Table 4b: GC/MS Summary of Oxycodone Discordant Results
--	--	---------------------------------------------------------	--

| Sample
No. | Screening Cutoff
(pg/mg) | ELISA Test
Result
(POS/NEG) | GC/MS Cutoff
(pg/mg) | GC/MS Drug Result (pg/mg) |
|---------------|-----------------------------|-----------------------------------|-------------------------|---------------------------|
| 835334 | 300 | NEG | 300 | OXY 169
HDC 167 |
| EXOP 39 | 300 | POS | 300 | OXY 131
HDC 83 |
| 788840 | 300 | POS | 300 | OXY 185
HDC 29 |
| 787180c | 300 | POS | 300 | OXY 229
HDC 68 |
| 789526 | 300 | POS | 300 | OXY 240
HDC 49 |
| 872104 | 300 | NEG | 300 | OXY 130
HDC 221 |

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	Table 4b: GC/MS Summary of Oxycodone Discordant Results

| Sample
No. | Screening Cutoff
(pg/mg) | ELISA Test
Result
(POS/NEG) | GC/MS Cutoff
(pg/mg) | GC/MS Drug Result (pg/mg) |
|---------------|-----------------------------|-----------------------------------|-------------------------|---------------------------|
| 854976 | 300 | POS | 300 | OXY 255 |
| 800488 | 300 | POS | 300 | OXY 298 |

Table 4c: Hydrocodone Summary of Agreement Study Results (n=500*)

| ELISA
Test
Result | Negative by
GC/MS | Less than half
the cutoff
concentration
by GC/MS | Near Cutoff
Negative
(Between 50%
below the
cutoff and the
cutoff
concentration) | Near Cutoff
Positive
(Between the
cutoff and 50%
above the cutoff
concentration) | High Positive
(Greater that
50% above
the cutoff
concentration) |
|-------------------------|----------------------|-----------------------------------------------------------|----------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------|
| Positive | 0 | 0 | 8 | 110 | 201 |
| Negative | 142 | 8 | 25 | 6 | 0 |

*Of the 530 samples compared in the HDC assays, 27 ELISA positive head hair samples were negative by GC/MS confirmation for hydrocodone but positive for oxycodone, one head hair test sample was lost during centrifugation and 2 ELISA head hair positive samples were not able to be confirmed by GC/MS which reduced the number of test samples reported here to 500.

Table 4d: GC/MS Summary of Hydrocodone Discordant Results
-----------------------------------------------------------

| Sample
No. | Screening Cutoff
(pg/mg) | ELISA Test
Result
(POS/NEG) | GC/MS Cutoff
(pg/mg) | GC/MS Drug Result (pg/mg) |
|---------------|-----------------------------|-----------------------------------|-------------------------|---------------------------|
| 787832 | 300 | NEG | 300 | HDC 403 |
| 89 | 300 | NEG | 300 | HDC 313 |
| 65 | 300 | NEG | 300 | HDC 334 |
| 835334 | 300 | NEG | 300 | HDC 167
OXY 169 |
| 872104 | 300 | NEG | 300 | HDC 221
OXY 130 |
| 835981a | 300 | NEG | 300 | HDC 347 |
| 788840 | 300 | POS | 300 | HDC 29
OXY 185 |
| 789526 | 300 | POS | 300 | HDC 49
OXY 240 |
| 787180c | 300 | POS | 300 | HDC 68
OXY 229 |

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| Sample
No. | Screening Cutoff
(pg/mg) | ELISA Test
Result
(POS/NEG) | GC/MS Cutoff
(pg/mg) | GC/MS Drug Result (pg/mg) |
|---------------|-----------------------------|-----------------------------------|-------------------------|---------------------------|
| EXOP 39 | 300 | POS | 300 | HDC 83
OXY 131 |
| 790194 | 300 | POS | 300 | HDC 204 |
| 849237 | 300 | POS | 300 | HDC 256 |
| 904316 | 300 | POS | 300 | HDC 272 |
| 780598 | 300 | POS | 300 | HDC 283 |

Table 4d: GC/MS Summary of Hydrocodone Discordant Results

CROSSREACTIVITY:

The Cross-reactivity study was designed to evaluate the specificity of the Omega Laboratories, Inc. ELISA Screening Protocol and the possible effect of interfering compounds.

Table 5a: Cross-reactivity of Opiates ELISA with Structurally Similar Compounds:

| Compound (pg/mg) Equivalent to 300pg/mg Cutoff Control
(n=3) | Percent Cross-
reactivity (%) | |
|-----------------------------|---- | Morphine | 300 | Heroin | 200 | Codeine | 250 | 6-Acetylcodeine | 275 | Ethylmorphine | 200 | Dihydrocodeine | 700 | 6-Monoacetylmorphine | 200 | Morphine-3-Beta-Glucuronide | 700 | Thebain | 1250 | Morphine-6-Beta-Glucuronide | 600 | Dihydromorphine | 1500 | Hydrocodone | 1250 | Hydromorphone | 2000 | Nalorphine | 7000 | Levorphanol | 4000 | Norcodeine | 250000 | Oxycodone | 225000 | Normorphine | 175000 | Diprenorphine | 225000 | Dextromethorphan | Approximate Concentration of Compound
Opiates
--------------------------------------------------------------------------------------------------------|----------------------------------|--|
| 100.0 | |
| 150.0 | |
| 120.0 | |
| 109.1 | |
| 150.0 | |
| 42.9 | |
| 150.0 | |
| 42.9 | |
| 24.0 | |
| 50.0 | |
| 20.0 | |
| 24.0 | |
| 15.0 | |
| 4.3 | |
| 7.5 | |
| 0.1 | |
| 0.1 | |
| 0.2 | |
| 0.1 | |
| Not achieved at highest spike concentration. | | |

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| Compound | Approximate Concentration of Compound
(pg/mg) Equivalent to 300pg/mg Opiates
Cutoff Control
(n=3) | Percent Cross-
reactivity (%) |
|---------------------|------------------------------------------------------------------------------------------------------------|----------------------------------|
| Naltrexone | Not achieved at highest spike concentration.
1000000 pg/mg | |
| Norbuprenorphine | Not achieved at highest spike concentration.
1000000 pg/mg | |
| Buprenorphine | Not achieved at highest spike concentration.
1000000 pg/mg | |
| Oxymorphone | 200000 | 0.2 |
| Naltriben | Not achieved at highest spike concentration.
1000000 pg/mg | |
| Nalmefene | Not achieved at highest spike concentration.
1000000 pg/mg | |
| Apomorphine | Not achieved at highest spike concentration.
1000000 pg/mg | |
| Naloxone | Not achieved at highest spike concentration.
1000000 pg/mg | |
| Noroxymorphone | Not achieved at highest spike concentration.
1000000 pg/mg | |
| Noroxycodone | Not achieved at highest spike concentration.
1000000 pg/mg | |
| 3-Methoxynaltrexone | Not achieved at highest spike concentration.
1000000 pg/mg | |

Table 5a: Cross-reactivity of Opiates ELISA with Structurally Similar Compounds:

Table 5b: Cross reactivity of ELISA Oxycodone with Structurally Similar Compounds

| Compound | Approximate Concentration of
Compound (pg/mg) Equivalent to
300pg/mg Oxycodone Cutoff Control
(n=3) | Percent Cross-reactivity
(%) | |
|--------------------------|--------------------------------------------------------------------------------------------------------------|---------------------------------|--|
| Hydrocodone | 250 | 120 | |
| Oxycodone | 300 | 100 | |
| Oxymorphone | 1500 | 20 | |
| Dihydrocodeine | 2500 | 12 | |
| 6-Acetylcodeine | 4000 | 7.5 | |
| Codeine | 4500 | 6.7 | |
| Ethylmorphine | 5000 | 6 | |
| Hydromorphone | 6000 | 5 | |
| Heroin | 15000 | 2 | |
| Dihydromorphine | 15000 | 2 | |
| Levorphanol | 15000 | 2 | |
| Compound | Approximate Concentration of
Compound (pg/mg) Equivalent to
300pg/mg Oxycodone Cutoff Control
(n=3) | Percent Cross-reactivity
(%) | |
| 6-Monoacetylmorphine | 20000 | 1.5 | |
| Morphine | 30000 | 1 | |
| Noroxycodone | 30000 | 1 | |
| Thebaine | 40000 | 0.75 | |
| Morphine-3-β-glucuronide | 150000 | 0.2 | |
| Naloxone | 250000 | 0.12 | |
| Norcodeine | 400000 | 0.07 | |
| Morphine-6-β-glucuronide | Not achieved at highest spike concentration.
40000 pg/mg | | |
| Norbuprenorphine | Not achieved at highest spike concentration.
40000 pg/mg | | |
| Buprenorphine | Not achieved at highest spike concentration.
40000 pg/mg | | |
| Noroxymorphone | Not achieved at highest spike concentration.
40000 pg/mg | | |
| Nalorphine | Not achieved at highest spike concentration.
40000 pg/mg | | |
| Normorphine | Not achieved at highest spike concentration.
400000 pg/mg | | |
| Diprenorphine | Not achieved at highest spike concentration.
400000 pg/mg | | |
| Dextromethorphan | Not achieved at highest spike concentration.
400000 pg/mg | | |
| Naltrexone | Not achieved at highest spike concentration.
400000 pg/mg | | |
| Naltriben | Not achieved at highest spike concentration.
400000 pg/mg | | |
| Nalmefene | Not achieved at highest spike concentration.
400000 pg/mg | | |
| Apomorphine | Not achieved at highest spike concentration.
400000 pg/mg | | |
| 3-Methoxy-naltrexone | Not achieved at highest spike concentration.
400000 pg/mg | | |

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Table 5b: Cross reactivity of ELISA Oxycodone with Structurally Similar Compounds

Effect of Interfering Compounds: A variety of structurally related and unrelated compounds were tested for interference at 10000ng/ml (40000pg/mg) in the Opiates ELISA and the Oxycodone ELISA assays. Negative hair extracts were spiked with morphine or oxycodone at -50% (125pg/mg), +125% (375pg/mg) and +150% (450pg/mg) of the Cutoff Concentration (300pg/mg). These were then additionally spiked with 10000ng/ml (400000pg/mg) of the structurally related compounds unless otherwise noted. The absorbances were compared to the 300 pg/mg Cutoff control (CO). Only compounds that were structurally cross-reactive interfered in the assay. These structurally related compounds produced a

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positive response due to sufficient cross-reactivity. No tested samples produced a negative result when expected to be positive. The analysis was performed in triplicate.

| Compound | -50% CO
(150pg/mg) | +125% CO
(375pg/mg) | +150% CO
(450pg/mg) |
|------------------------------------------------------|-----------------------|------------------------|------------------------|
| (-) 11-nor-9-carboxy-delta8-
Tetrahydrocannabinol | NEG | POS | POS |
| (-) 11-nor-9-carboxy-delta9-
Tetrahydrocannabinol | NEG | POS | POS |
| R (-) Amphetamine | NEG | POS | POS |
| (-) Cotinine | NEG | POS | POS |
| (-) Cotinine -N-oxide | NEG | POS | POS |
| (-) Isoproterenol | NEG | POS | POS |
| (-) Methamphetamine | NEG | POS | POS |
| (-) Nicotine | NEG | POS | POS |
| (-) Phenylephrine | NEG | POS | POS |
| (-)-Alpha-methadol | NEG | POS | POS |
| (+) Amphetamine | NEG | POS | POS |
| (+) Isoproterenol | NEG | POS | POS |
| (+) Methamphetamine | NEG | POS | POS |
| (+) Pseudoephedrine | NEG | POS | POS |
| (±) 11-nor-9-carboxy-delta9-
Tetrahydrocannabinol | NEG | POS | POS |
| (±) 2,5-Dimethoxy- 4-bromoamphetamine | NEG | POS | POS |
| (±) Alphaprodine | NEG | POS | POS |
| (±) Ketamine | NEG | POS | POS |
| (±) MBDB | NEG | POS | POS |
| (±) MDA | NEG | POS | POS |
| (±) MDEA | NEG | POS | POS |
| (±) MDMA | NEG | POS | POS |
| (±) Metanephrine | NEG | POS | POS |
| (±) Metoprolol | NEG | POS | POS |
| (±) Norcotinine | NEG | POS | POS |
| (±) Propanolol | NEG | POS | POS |
| (±) Trans-3'-Hydroxycotinine | NEG | POS | POS |
| 11-Hydroxy-delta9-Tetrahydrocannabinol | NEG | POS | POS |
| 19-Nortestosterone (Nandrolone) | NEG | POS | POS |
| 1R,2S (-) Ephedrine | NEG | POS | POS |
| 1S,2R (+) Ephedrine | NEG | POS | POS |
| Compound | -50% CO
(150pg/mg) | +125% CO
(375pg/mg) | +150% CO
(450pg/mg) |
| 2-Oxo-3-hydroxy-LSD | NEG | POS | POS |
| 3-Methoxynaltrexone | NEG | POS | POS |
| 3-Trans-Hydroxy-norcotinine | NEG | POS | POS |
| 4-Acetoamidophenol | NEG | POS | POS |
| 4-Hydroxy-Phencyclidine | NEG | POS | POS |
| 5,5-Diphenylhydantoin | NEG | POS | POS |
| 6-Acetyl-codeine | POS | POS | POS |
| 6-MonoacetyImorphine | POS | POS | POS |
| 7-Aminoclonazepam | NEG | POS | POS |
| 7-Aminonitrazepam | NEG | POS | POS |
| Acebutolol | NEG | POS | POS |
| Acetophenetidin | NEG | POS | POS |
| Acetopromazine | NEG | POS | POS |
| Acetylsalicyclic acid | NEG | POS | POS |
| Alfentanil | NEG | POS | POS |
| Alpha-Ergocryptine | NEG | POS | POS |
| Alprazolam | NEG | POS | POS |
| 7-Aminoflunitrazepam | NEG | POS | POS |
| Aminorex | NEG | POS | POS |
| Amitriptyline | NEG | POS | POS |
| Amobarbital | NEG | POS | POS |
| Amoxicillin | NEG | POS | POS |
| Anhydroecgonine | NEG | POS | POS |
| Anileridine | NEG | POS | POS |
| Apomorphine | NEG | POS | POS |
| Atenolol | NEG | POS | POS |
| Azaperone | NEG | POS | POS |
| Benzoylecgonine | NEG | POS | POS |
| Benzoylecgonine isopropyl ester | NEG | POS | POS |
| Betamethasone | NEG | POS | POS |
| Boldenone | NEG | POS | POS |
| Bumetanide | NEG | POS | POS |
| Bupivicaine | NEG | POS | POS |
| Buprenorphine | POS | POS | POS |
| Compound | -50% CO
(150pg/mg) | +125% CO
(375pg/mg) | +150% CO
(450pg/mg) |
| Buprenorphine-glucuronide
(2500ng/ml) | NEG | POS | POS |
| Buspirone | NEG | POS | POS |
| Butabarbital | NEG | POS | POS |
| Butalbital | NEG | POS | POS |
| Caffeine | NEG | POS | POS |
| Cannabidiol | NEG | POS | POS |
| Cannabinol | NEG | POS | POS |
| Carbamazepine | NEG | POS | POS |
| Carisoprodol | NEG | POS | POS |
| Chlordiazepoxide | NEG | POS | POS |
| Chlorpromazine | NEG | POS | POS |
| Cimeterol | NEG | POS | POS |
| Clenbuterol | NEG | POS | POS |
| Clomipramine | NEG | POS | POS |
| Clonazepam | NEG | POS | POS |
| Clonidine | NEG | POS | POS |
| Clozapine | NEG | POS | POS |
| Cocaethylene | NEG | POS | POS |
| Cocaine | NEG | POS | POS |
| Codeine | POS | POS | POS |
| Corticosterone | NEG | POS | POS |
| Cortisone | NEG | POS | POS |
| Cotinine-N-beta-D-Glucuronide | NEG | POS | POS |
| Cyclobenzaprine | NEG | POS | POS |
| d, I-N-Desmethylvenlafaxine | NEG | POS | POS |
| Delta8-Tetrahydrocannabinol | NEG | POS | POS |
| Delta9-Tetrahydrocannabinol | NEG | POS | POS |
| Deoxycorticosterone | NEG | POS | POS |
| Desalkylflurazepam | NEG | POS | POS |
| Desipramine | NEG | POS | POS |
| Desmethyldoxepin (cis/trans) | NEG | POS | POS |
| Despropionyl-fentanyl | NEG | POS | POS |
| Dexamethasone | NEG | POS | POS |
| Compound | -50% CO
(150pg/mg) | +125% CO
(375pg/mg) | +150% CO
(450pg/mg) |
| Dextromethorphan | NEG | POS | POS |
| Diazepam | NEG | POS | POS |
| Dibucaine | NEG | POS | POS |
| Dihydrocodeine | POS | POS | POS |
| Dihydroergotamine | NEG | POS | POS |
| Dihydromorphine | POS | POS | POS |
| Diphenhydramine | NEG | POS | POS |
| Diphenoxylate | NEG | POS | POS |
| Diprenorphine | POS | POS | POS |
| Dothiepin (cis/trans) | NEG | POS | POS |
| Doxepin | NEG | POS | POS |
| Doxylamine | NEG | POS | POS |
| Droperidol | NEG | POS | POS |
| Ecgonine | NEG | POS | POS |
| Ecgonine methyl ester | NEG | POS | POS |
| EDDP | NEG | POS | POS |
| Effexor (Venlafaxine) | NEG | POS | POS |
| EMDP | NEG | POS | POS |
| Ergonovine | NEG | POS | POS |
| Erythromycin | NEG | POS | POS |
| Estazolam | NEG | POS | POS |
| Ethacrynic acid | NEG | POS | POS |
| Ethopropazine | NEG | POS | POS |
| Ethylmorphine | POS | POS | POS |
| Fenfluramine | NEG | POS | POS |
| Fentanyl | NEG | POS | POS |
| Flumethasone | NEG | POS | POS |
| Flunitrazepam | NEG | POS | POS |
| Fluphenazine | NEG | POS | POS |
| Flurazepam | NEG | POS | POS |
| Furosemide | NEG | POS | POS |
| Gentamicin | NEG | POS | POS |
| Gluthimide | NEG | POS | POS |
| Haloperidol | NEG | POS | POS |
| Compound | -50% CO
(150pg/mg) | +125% CO
(375pg/mg) | +150% CO
(450pg/mg) |
| Heroin | POS | POS | POS |
| Hexobarbital | NEG | POS | POS |
| HMMA | NEG | POS | POS |
| Hydrochlorothiazide | NEG | POS | POS |
| Hydrocodone | POS | POS | POS |
| Hydrocortisone | NEG | POS | POS |
| Hydromorphone | POS | POS | POS |
| (±) 4-Hydroxyephedrine | NEG | POS | POS |
| Hydroxymethamphetamine | NEG | POS | POS |
| Ibogaine | NEG | POS | POS |
| Ibuprofen | NEG | POS | POS |
| Imipramine | NEG | POS | POS |
| Ketoprofen | NEG | POS | POS |
| LAAM | NEG | POS | POS |
| Labetalol | NEG | POS | POS |
| Levorphanol | POS | POS | POS |
| L-Hyoscyamine | NEG | POS | POS |
| Lidocaine | NEG | POS | POS |
| Lorazepam | NEG | POS | POS |
| LSD | NEG | POS | POS |
| Lysergic acid | NEG | POS | POS |
| Lysergol | NEG | POS | POS |
| Maprotiline | NEG | POS | POS |
| Meperidine | NEG | POS | POS |
| Mephentermine | NEG | POS | POS |
| Mepivacaine | NEG | POS | POS |
| Metaphit | NEG | POS | POS |
| Metaproterenol | NEG | POS | POS |
| Metaraminol | NEG | POS | POS |
| Methadone | NEG | POS | POS |
| Methohexital | NEG | POS | POS |
| Methoxyphenamine | NEG | POS | POS |
| Methylergonovine | NEG | POS | POS |
| Methylphenidate | NEG | POS | POS |
| Compound | -50% CO
(150pg/mg) | +125% CO
(375pg/mg) | +150% CO
(450pg/mg) |
| m-Hydroxybenzoylecgonine | NEG | POS | POS |
| Mianserin | NEG | POS | POS |
| Midazolam | NEG | POS | POS |
| Monensin | NEG | POS | POS |
| Morphine | POS | POS | POS |
| Morphine-3-betaglucuronide | POS | POS | POS |
| Morphine-6-betaglucuronide | POS | POS | POS |
| Nadolol | NEG | POS | POS |
| Nalmefene | NEG | POS | POS |
| Nalorphine | POS | POS | POS |
| Naloxone-3-beta-D-glucuronide | NEG | POS | POS |
| Naltrexone | NEG | POS | POS |
| Naltriben | NEG | POS | POS |
| Naproxen | NEG | POS | POS |
| N-Desmethylclomipramine | NEG | POS | POS |
| N-Desmethylflunitrazepam | NEG | POS | POS |
| N-Desmethyltramadol | NEG | POS | POS |
| N-Desmethyltrimipramine | NEG | POS | POS |
| Neomycin | NEG | POS | POS |
| Nitrazepam | NEG | POS | POS |
| Norbenzoylecgonine | NEG | POS | POS |
| Norbuprenorphine | NEG | POS | POS |
| Norcocaethylene | NEG | POS | POS |
| Norcocaine | NEG | POS | POS |
| Norcodeine | POS | POS | POS |
| Nordiazepam | NEG | POS | POS |
| Norfentanyl | NEG | POS | POS |
| Nor-LAAM | NEG | POS | POS |
| Nor-LSD/Nor-ISO-LSD | NEG | POS | POS |
| Normeperidine | NEG | POS | POS |
| Normeperidinic acid | NEG | POS | POS |
| Normorphine | POS | POS | POS |
| Noroxycodone | NEG | POS | POS |
| Noroxymorphone | POS | POS | POS |
| Compound | -50% CO
(150pg/mg) | +125% CO
(375pg/mg) | +150% CO
(450pg/mg) |
| Norpropoxyphene | NEG | POS | POS |
| Nortriptyline | NEG | POS | POS |
| Noscapine | NEG | POS | POS |
| O-Desmethyltramadol | NEG | POS | POS |
| Oxazepam | NEG | POS | POS |
| Oxprenolol | NEG | POS | POS |
| Oxycodone | POS | POS | POS |
| Oxymorphone | POS | POS | POS |
| p-Acetamidophenyl-beta-D-glucuronide | NEG | POS | POS |
| Papaverine | NEG | POS | POS |
| Pemoline | NEG | POS | POS |
| Penicillin G | NEG | POS | POS |
| Pentazocine | NEG | POS | POS |
| Pentobarbital | NEG | POS | POS |
| Perphenazine | NEG | POS | POS |
| Phendimetrazine | NEG | POS | POS |
| Phenelzine | NEG | POS | POS |
| Phenobarbital | NEG | POS | POS |
| Phenothiazine | NEG | POS | POS |
| Phentermine | NEG | POS | POS |
| Phenylbutazone | NEG | POS | POS |
| Phenylethyamine | NEG | POS | POS |
| Phenylpropanolamine | NEG | POS | POS |
| PMA | NEG | POS | POS |
| PMMA | NEG | POS | POS |
| Prednisolone | NEG | POS | POS |
| Prilocaine | NEG | POS | POS |
| Prochlorperazine | NEG | POS | POS |
| Progesterone | NEG | POS | POS |
| Promazine | NEG | POS | POS |
| Promethazine | NEG | POS | POS |
| Propiomazine | NEG | POS | POS |
| Propionylpromazine | NEG | POS | POS |
| Propoxyphene | NEG | POS | POS |
| Compound | -50% CO
(150pg/mg) | +125% CO
(375pg/mg) | +150% CO
(450pg/mg) |
| Protriptyline | NEG | POS | POS |
| Quinidine | NEG | POS | POS |
| R (+) Methcathinone | NEG | POS | POS |
| R (-) Epinephrine | NEG | POS | POS |
| R (+) Cathinone | NEG | POS | POS |
| Salbutamol | NEG | POS | POS |
| Secobarbital | NEG | POS | POS |
| Sertraline | NEG | POS | POS |
| Stanazalol | NEG | POS | POS |
| Streptomycin | NEG | POS | POS |
| Sulfadimethoxine | NEG | POS | POS |
| Sulfamethazine | NEG | POS | POS |
| Sulfathiazole | NEG | POS | POS |
| Temazepam | NEG | POS | POS |
| Terbutaline | NEG | POS | POS |
| Tetracycline | NEG | POS | POS |
| Thebaine | POS | POS | POS |
| Theophylline | NEG | POS | POS |
| Thioridazine | NEG | POS | POS |
| Tramadol | NEG | POS | POS |
| Triamcinolone | NEG | POS | POS |
| Triazolam | NEG | POS | POS |
| Trifluoperazine | NEG | POS | POS |
| Trifluopromazine | NEG | POS | POS |
| Trimeprazine | NEG | POS | POS |
| Trimipramine | NEG | POS | POS |
| Tylosin | NEG | POS | POS |
| Tyramine | NEG | POS | POS |
| Yohimbic acid | NEG | POS | POS |
| Yohimbine | NEG | POS | POS |
| Zolpidem | NEG | POS | POS |
| Zopiclone | NEG | POS | POS |
| Phencyclidine | NEG | POS | POS |
| R,R (-)-Pseudoephedrine | NEG | POS | POS |
| Compound | -50% CO
(150pg/mg) | +125% CO
(375pg/mg) | +150% CO
(450pg/mg) |
| Phencyclidine Morpholine | NEG | POS | POS |

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Table 5c: Interferences of Structurally Related and Unrelated Compounds on Opiates ELISA Assay

Table 5d: Interferences of Structurally Related and Unrelated Compounds on Oxycodone ELISA Sys

| Compound | -50% CO
(150pg/mg) | +125% CO
(375pg/mg) | +150% CO
(450pg/mg) |
|------------------------------------------------------|-----------------------|------------------------|------------------------|
| (-) 11-nor-9-carboxy-delta8-
Tetrahydrocannabinol | NEG | POS | POS |
| (-) 11-nor-9-carboxy-delta9-
Tetrahydrocannabinol | NEG | POS | POS |
| R (-) Amphetamine | NEG | POS | POS |
| (-) Cotinine | NEG | POS | POS |
| (-) Cotinine -N-oxide | NEG | POS | POS |
| (-) Isoproterenol | NEG | POS | POS |
| (-) Methamphetamine | NEG | POS | POS |
| (-) Nicotine | NEG | POS | POS |
| (-) Phenylephrine | NEG | POS | POS |
| (-)-Alpha-methadol | NEG | POS | POS |
| (+) Amphetamine | NEG | POS | POS |
| (+) Isoproterenol | NEG | POS | POS |
| (+) Methamphetamine | NEG | POS | POS |
| (+) Pseudoephedrine | NEG | POS | POS |
| (±) 11-nor-9-carboxy-delta9-
Tetrahydrocannabinol | NEG | POS | POS |
| (±) 2,5-Dimethoxy- 4-bromoamphetamine | NEG | POS | POS |
| (±) Alphaprodine | NEG | POS | POS |
| (±) Ketamine | NEG | POS | POS |
| (±) MBDB | NEG | POS | POS |
| (±) MDA | NEG | POS | POS |
| (±) MDEA | NEG | POS | POS |
| (±) MDMA | NEG | POS | POS |
| (±) Metanephrine | NEG | POS | POS |
| (±) Metoprolol | NEG | POS | POS |
| (±) Norcotinine | NEG | POS | POS |
| (±) Propanolol | NEG | POS | POS |
| Compound | -50% CO
(150pg/mg) | +125% CO
(375pg/mg) | +150% CO
(450pg/mg) |
| (±) Trans-3'-Hydroxycotinine | NEG | POS | POS |
| 11-Hydroxy-delta9-Tetrahydrocannabinol | NEG | POS | POS |
| 19-Nortestosterone (Nandrolone) | NEG | POS | POS |
| 1R,2S (-) Ephedrine | NEG | POS | POS |
| 1S,2R (+) Ephedrine | NEG | POS | POS |
| 2-Oxo-3-hydroxy-LSD | NEG | POS | POS |
| 3-Methoxynaltrexone | POS | POS | POS |
| 3-Trans-Hydroxy-norcotinine | NEG | POS | POS |
| 4-Acetoamidophenol | NEG | POS | POS |
| 4-Hydroxy-Phencyclidine | NEG | POS | POS |
| 5,5-Diphenylhydantoin | NEG | POS | POS |
| 6-Acetyl-codeine | POS | POS | POS |
| 6-MonoacetyImorphine | POS | POS | POS |
| 7-Aminoclonazepam | NEG | POS | POS |
| 7-Aminonitrazepam | NEG | POS | POS |
| Acebutolol | NEG | POS | POS |
| Acetophenetidin | NEG | POS | POS |
| Acetopromazine | NEG | POS | POS |
| AcetyIsalicyclic acid | NEG | POS | POS |
| Alfentanil | NEG | POS | POS |
| Alpha-Ergocryptine | NEG | POS | POS |
| Alprazolam | NEG | POS | POS |
| 7-Aminoflunitrazepam | NEG | POS | POS |
| Aminorex | NEG | POS | POS |
| Amitriptyline | NEG | POS | POS |
| Amobarbital | NEG | POS | POS |
| Amoxicillin | NEG | POS | POS |
| Anhydroecgonine | NEG | POS | POS |
| Anileridine | NEG | POS | POS |
| Apomorphine | NEG | POS | POS |
| Atenolol | NEG | POS | POS |
| Atropine | NEG | POS | POS |
| Azaperone | NEG | POS | POS |
| Benzoylecgonine | NEG | POS | POS |

22

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Table 5d: Interferences of Structurally Related and Unrelated Compounds on Oxycodone ELISA Sys

23

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| Compound | -50% CO
(150pg/mg) | +125% CO
(375pg/mg) | +150% CO
(450pg/mg) |
|---------------------------------|-----------------------|------------------------|------------------------|
| Benzoylecgonine isopropyl ester | NEG | POS | POS |
| Betamethasone | NEG | POS | POS |
| Boldenone | NEG | POS | POS |
| Bumetanide | NEG | POS | POS |
| Bupivicaine | NEG | POS | POS |
| Buprenorphine | NEG | POS | POS |
| Buspirone | NEG | POS | POS |
| Butabarbital | NEG | POS | POS |
| Butalbital | NEG | POS | POS |
| Caffeine | NEG | POS | POS |
| Cannabidiol | NEG | POS | POS |
| Cannabinol | NEG | POS | POS |
| Carbamazepine | NEG | POS | POS |
| Carisoprodol | NEG | POS | POS |
| Chlordiazepoxide | NEG | POS | POS |
| Chlorpromazine | NEG | POS | POS |
| Cimeterol | NEG | POS | POS |
| Clenbuterol | NEG | POS | POS |
| Clomipramine | NEG | POS | POS |
| Clonazepam | NEG | POS | POS |
| Clonidine | NEG | POS | POS |
| Clozapine | NEG | POS | POS |
| Cocaethylene | NEG | POS | POS |
| Cocaine | NEG | POS | POS |
| Codeine | POS | POS | POS |
| Corticosterone | NEG | POS | POS |
| Cortisone | NEG | POS | POS |
| Cotinine-N-beta-D-Glucuronide | NEG | POS | POS |
| Cyclobenzaprine | NEG | POS | POS |
| d,I-N-Desmethylvenlafaxine | NEG | POS | POS |
| Delta8-Tetrahydrocannabinol | NEG | POS | POS |
| Delta9-Tetrahydrocannabinol | NEG | POS | POS |
| Deoxycorticosterone | NEG | POS | POS |
| Desalkylflurazepam | NEC | POS | POS |

Table 5d: Interferences of Structurally Related and Unrelated Compounds on Oxycodone ELISA Sys

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| Compound | -50% CO
(150pg/mg) | +125% CO
(375pg/mg) | +150% CO
(450pg/mg) |
|------------------------------|-----------------------|------------------------|------------------------|
| Desipramine | NEG | POS | POS |
| Desmethyldoxepin (cis/trans) | NEG | POS | POS |
| Despropionyl-fentanyl | NEG | POS | POS |
| Dexamethasone | NEG | POS | POS |
| Dextromethorphan | NEG | POS | POS |
| Diazepam | NEG | POS | POS |
| Dibucaine | NEG | POS | POS |
| Dihydrocodeine | POS | POS | POS |
| Dihydroergotamine | NEG | POS | POS |
| Dihydromorphine | POS | POS | POS |
| Diphenhydramine | NEG | POS | POS |
| Diphenoxylate | NEG | POS | POS |
| Diprenorphine | NEG | POS | POS |
| Dothiepin (cis/trans) | NEG | POS | POS |
| Doxepin | NEG | POS | POS |
| Doxylamine | NEG | POS | POS |
| Droperidol | NEG | POS | POS |
| Ecgonine | NEG | POS | POS |
| Ecgonine methyl ester | NEG | POS | POS |
| EDDP | NEG | POS | POS |
| Effexor (Venlafaxine) | NEG | POS | POS |
| EMDP | NEG | POS | POS |
| Ergonovine | NEG | POS | POS |
| Erythromycin | NEG | POS | POS |
| Estazolam | NEG | POS | POS |
| Ethacrynic acid | NEG | POS | POS |
| Ethopropazine | NEG | POS | POS |
| Ethylmorphine | POS | POS | POS |
| Fenfluramine | NEG | POS | POS |
| Fentanyl | NEG | POS | POS |
| Flumethasone | NEG | POS | POS |
| Flunitrazepam | NEG | POS | POS |
| Fluphenazine | NEG | POS | POS |
| Flurazepam | NEG | POS | POS |

Table 5d: Interferences of Structurally Related and Unrelated Compounds on Oxycodone ELISA Sys

25

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| Compound | -50% CO
(150pg/mg) | +125% CO
(375pg/mg) | +150% CO
(450pg/mg) |
|------------------------|-----------------------|------------------------|------------------------|
| Furosemide | NEG | POS | POS |
| Gentamicin | NEG | POS | POS |
| Gluthimide | NEG | POS | POS |
| Haloperidol | NEG | POS | POS |
| Heroin | POS | POS | POS |
| Hexobarbital | NEG | POS | POS |
| HMMA | NEG | POS | POS |
| Hydrochlorothiazide | NEG | POS | POS |
| Hydrocodone | POS | POS | POS |
| Hydrocortisone | NEG | POS | POS |
| Hydromorphone | POS | POS | POS |
| (±) 4-Hydroxyephedrine | NEG | POS | POS |
| Hydroxymethamphetamine | NEG | POS | POS |
| Ibogaine | NEG | POS | POS |
| Ibuprofen | NEG | POS | POS |
| Imipramine | NEG | POS | POS |
| Ketoprofen | NEG | POS | POS |
| LAAM | NEG | POS | POS |
| Labetalol | NEG | POS | POS |
| LAMPA (1000ng/ml) | NEG | POS | POS |
| Levorphanol | POS | POS | POS |
| L-Hyoscyamine | NEG | POS | POS |
| Lidocaine | NEG | POS | POS |
| Lorazepam | NEG | POS | POS |
| LSD | NEG | POS | POS |
| Lysergic acid | NEG | POS | POS |
| Lysergol | NEG | POS | POS |
| Maprotiline | NEG | POS | POS |
| Meperidine | NEG | POS | POS |
| Mephentermine | NEG | POS | POS |
| Mepivacaine | NEG | POS | POS |
| Metaphit | NEG | POS | POS |
| Metaproterenol | NEG | POS | POS |
| Metaraminol | NEG | POS | POS |

Table 5d: Interferences of Structurally Related and Unrelated Compounds on Oxycodone ELISA Sys

26

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| Compound | -50% CO
(150pg/mg) | +125% CO
(375pg/mg) | +150% CO
(450pg/mg) |
|-------------------------------|-----------------------|------------------------|------------------------|
| Methadone | NEG | POS | POS |
| Methohexital | NEG | POS | POS |
| Methoxyphenamine | NEG | POS | POS |
| Methylergonovine | NEG | POS | POS |
| Methylphenidate | NEG | POS | POS |
| m-Hydroxybenzoylecgonine | NEG | POS | POS |
| Mianserin | NEG | POS | POS |
| Midazolam | NEG | POS | POS |
| Monensin | NEG | POS | POS |
| Morphine | POS | POS | POS |
| Morphine-3-beta-glucuronide | POS | POS | POS |
| Morphine-6-beta-glucuronide | POS | POS | POS |
| Nadolol | NEG | POS | POS |
| Nalmefene | POS | POS | POS |
| Nalorphine | POS | POS | POS |
| Naloxone-3-beta-D-glucuronide | POS | POS | POS |
| Naltrexone | POS | POS | POS |
| Naltriben | POS | POS | POS |
| Naproxen | NEG | POS | POS |
| N-Desmethylclomipramine | NEG | POS | POS |
| N-Desmethylflunitrazepam | NEG | POS | POS |
| N-Desmethyltramadol | NEG | POS | POS |
| N-Desmethyltrimipramine | NEG | POS | POS |
| Neomycin | NEG | POS | POS |
| Nitrazepam | NEG | POS | POS |
| Norbenzoylecgonine | NEG | POS | POS |
| Norbuprenorphine | NEG | POS | POS |
| Norcocaethylene | NEG | POS | POS |
| Norcocaine | NEG | POS | POS |
| Norcodeine | POS | POS | POS |
| Nordiazepam | NEG | POS | POS |
| Norfentanyl | NEG | POS | POS |
| Nor-LAAM | NEG | POS | POS |
| Nor-LSD/Nor-ISO-LSD | NEG | POS | POS |

Table 5d: Interferences of Structurally Related and Unrelated Compounds on Oxycodone ELISA Sys

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| Compound | -50% CO
(150pg/mg) | +125% CO
(375pg/mg) | +150% CO
(450pg/mg) |
|--------------------------------------|-----------------------|------------------------|------------------------|
| Normeperidine | NEG | POS | POS |
| Normeperidinic acid | NEG | POS | POS |
| Normorphine | POS | POS | POS |
| Noroxycodone | POS | POS | POS |
| Noroxymorphone | POS | POS | POS |
| Norpropoxyphene | NEG | POS | POS |
| Nortriptyline | NEG | POS | POS |
| Noscapine | NEG | POS | POS |
| O-Desmethyltramadol | NEG | POS | POS |
| Oxazepam | NEG | POS | POS |
| Oxprenolol | NEG | POS | POS |
| Oxycodone | POS | POS | POS |
| Oxymorphone | POS | POS | POS |
| p-Acetamidophenyl-beta-D-glucuronide | NEG | POS | POS |
| Papaverine | NEG | POS | POS |
| Pemoline | NEG | POS | POS |
| Penicillin G | NEG | POS | POS |
| Pentazocine | NEG | POS | POS |
| Pentobarbital | NEG | POS | POS |
| Perphenazine | NEG | POS | POS |
| Phendimetrazine | NEG | POS | POS |
| Phenelzine | NEG | POS | POS |
| Phenobarbital | NEG | POS | POS |
| Phenothiazine | NEG | POS | POS |
| Phentermine | NEG | POS | POS |
| Phenylbutazone | NEG | POS | POS |
| Phenylethyamine | NEG | POS | POS |
| Phenylpropanolamine | NEG | POS | POS |
| Phencyclidine | NEG | POS | POS |
| R,R (-)-Pseudoephedrine | NEG | POS | POS |
| Phencyclidine Morpholine | NEG | POS | POS |
| PMA | NEG | POS | POS |
| PMMA | NEG | POS | POS |
| Prednisolone | NEG | POS | POS |

Table 5d: Interferences of Structurally Related and Unrelated Compounds on Oxycodone ELISA Sys

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| Compound | -50% CO
(150pg/mg) | +125% CO
(375pg/mg) | +150% CO
(450pg/mg) |
|---------------------|-----------------------|------------------------|------------------------|
| Prilocaine | NEG | POS | POS |
| Prochlorperazine | NEG | POS | POS |
| Progesterone | NEG | POS | POS |
| Promazine | NEG | POS | POS |
| Promethazine | NEG | POS | POS |
| Propiomazine | NEG | POS | POS |
| Propionylpromazine | NEG | POS | POS |
| Propoxyphene | NEG | POS | POS |
| Protriptyline | NEG | POS | POS |
| Quinidine | NEG | POS | POS |
| R (+) Methcathinone | NEG | POS | POS |
| R (-) Epinephrine | NEG | POS | POS |
| R (+) Cathinone | NEG | POS | POS |
| Salbutamol | NEG | POS | POS |
| Secobarbital | NEG | POS | POS |
| Sertraline | NEG | POS | POS |
| Stanazalol | NEG | POS | POS |
| Streptomycin | NEG | POS | POS |
| Sulfadimethoxine | NEG | POS | POS |
| Sulfamethazine | NEG | POS | POS |
| Sulfathiazole | NEG | POS | POS |
| Temazepam | NEG | POS | POS |
| Terbutaline | NEG | POS | POS |
| Tetracycline | NEG | POS | POS |
| Thebaine | POS | POS | POS |
| Theophylline | NEG | POS | POS |
| Thioridazine | NEG | POS | POS |
| Tramadol | NEG | POS | POS |
| Triamcinolone | NEG | POS | POS |
| Triazolam | NEG | POS | POS |
| Trifluoperazine | NEG | POS | POS |
| Trifluopromazine | NEG | POS | POS |
| Trimeprazine | NEG | POS | POS |
| Trimipramine | NEG | POS | POS |

Table 5d: Interferences of Structurally Related and Unrelated Compounds on Oxycodone ELISA Sys

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| Compound | -50% CO
(150pg/mg) | +125% CO
(375pg/mg) | +150% CO
(450pg/mg) |
|---------------|-----------------------|------------------------|------------------------|
| Tylosin | NEG | POS | POS |
| Tyramine | NEG | POS | POS |
| Yohimbic acid | NEG | POS | POS |
| Yohimbine | NEG | POS | POS |
| Zolpidem | NEG | POS | POS |
| Zopiclone | NEG | POS | POS |

Table 5d: Interferences of Structurally Related and Unrelated Compounds on Oxycodone ELISA Sys

This study demonstrated that the presence of the structurally similar compounds Buprenorphine, Noroxymorphone, 3-Methoxynaltrexone, Morphine-6-beta-glucuronide, Nalmefene, Nalorphine, Naloxone-3-beta-D-glucuronide, Naltriben, and Noroxymorphone, may contribute to an Opiate or Oxycodone positive ELISA result when utilizing this protocol.

To better under the observed cross-reactivity of the above identified compounds, the concentration ranges were extended to generate additional cross-reactivity (CR) data. With the extremely high concentrations, some cross-reactivity was now observable in all except for Nalmefene, Naloxone-3-beta-D-glucuronide and Naltriben.

The interference tests were also rerun at -50% of cutoffs. There was good correlation with the previous dataset. One interference test produced a different outcome. Specifically, Noroxymorphone in opiates assay. The calculated equivalents based on the CR curve resulted in a calculated equivalent concentration close to the assay cutoff.

| Compound | Concentration of
Compound (pg/mg)
Equivalent to 300 pg/mg
Opiates Cutoff Control | Percent Cross-
Reactivity (%) |
|----------------------------|-------------------------------------------------------------------------------------------|----------------------------------|
| Morphine-6-β-D-glucuronide | 800 | 37.5 |
| Nalorphine | 8500 | 3.5 |
| Buprenorphine | 600000 | 0.050 |
| 3-Methoxynaltrexone | 900000 | 0.033 |
| Naltrexone | 3000000 | 0.010 |
| Noroxymorphone | 4000000 | 0.008 |
| Nalmefene | * | 0.00 |
| Naloxone-3-β-D-glucuronide | * | 0.00 |
| Naltriben | * | 0.00 |

5e: Cross reactivity of Opiates ELISA with Structurally Similar Compounds

Unable to generate an assay absorbance equivalent to 300pg/mg Opiates cutoff. Highest concentration tested was 4,000,000pg/mg.

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Compounds	ELISA Assay Results	Opiates equivalents (pg/mg)
Morphine 6-β-D-glucuronide	POS	150300
Nalorphine	POS	14300
Buprenorphine	POS	500
3-Methoxynaltrexone	NEG	432
Naltrexone	NEG	340
Noroxymorphone	NEG	332
Nalmefene	NEG	332
Naloxone 3-β-D-glucuronide	NEG	332
Naltriben	NEG	332

Table 5f: Interferences of Structurally Related and Unrelated Compounds on Opiates ELISA Assay All results at the -50% of cutoff

Table 5g: Cross Reactivity of Omega Laboratories, Inc. Oxycodone ELISA with Structurally Similar Compounds

| Compound | Concentration of Compound
(pg/mg) Equivalent to 300
pg/mg Oxycodone Cutoff
Control | Percent Cross-
Reactivity (%) |
|----------------------------|---------------------------------------------------------------------------------------------|----------------------------------|
| Morphine-6-β-D-glucuronide | 31000 | 0.97 |
| Nalorphine | 300000 | 0.10 |
| Buprenorphine | * | 0.00 |
| 3-Methoxynaltrexone | 380000 | 0.08 |
| Naltrexone | 50000 | 0.60 |
| Noroxymorphone | 58000 | 0.52 |
| Nalmefene | 300000 | 0.10 |
| Naloxone-3-β-D-glucuronide | 680000 | 0.04 |
| Naltriben | 300000 | 0.10 |

Unable to generate an assay absorbance equivalent to 300pg/mg Oxycodone cutoff. Highest concentration tested was 4,000,000pg/mg

Table 5h: Interferences of Structurally Related and Unrelated Compounds on Oxycodone ELISA Assay All results at the -50% of cutoff

| Compound | ELISA Assay
Results | Oxycodone equivalents
(pg/mg) |
|----------------------------|------------------------|----------------------------------|
| Morphine 6-β-D-glucuronide | POS | 4,180 |
| Nalorphine | POS | 700 |
| Buprenorphine | NEG | 340 |
| 3-Methoxynaltrexone | POS | 620 |

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| Compound | ELISA Assay
Results | Oxycodone equivalents
(pg/mg) |
|----------------------------|------------------------|----------------------------------|
| Naltrexone | POS | 2,700 |
| Noroxymorphone | POS | 2,380 |
| Nalmefene | POS | 700 |
| Naloxone 3-β-D-glucuronide | POS | 460 |
| Naltriben | POS | 340 |

Table 5h: Interferences of Structurally Related and Unrelated Compounds on Oxycodone ELISA Assay All results at the -50% of cutoff

None of the other compounds studied demonstrated any interference with the protocol.

CALIBRATOR AND CONTROL:

The Omega Laboratories, Inc. ELISA Opiates and Oxycodone Screening Protocols utilize in-house prepared calibrators and control solutions. The study successfully demonstrated the validation and stability of these solutions and the traceability to NIST standards.

The data demonstrating the stability of morphine and oxycodone in methanol for a period of one year when stored refrigerated in an amber bottle was provide as part of K103161. The quantitative values of 271 and 291 pg/mg for morphine and oxycodone, respectively, after a one year period is within 10% of the target value of 300 pg/mg. The study validated the one 1 year expiration date for the Calibrator Stock Solution.

STABILITY:

Hair samples were taken from the head were packaged (stored) in the Omega Collection Kit (The Hair Collection Kit consists of a poly transport bag, a small piece of foil, a small specimen pouch (envelope). The Collection Kit, containing the hair sample was previously confirmed positive then stored for an average of 3.1 years for opiate samples and stored for approximately 2 years for oxycodone and hydrocodone samples.

Fifty-four samples varying in ethnic origin, hair color and curvature were tested.

Study Observation	Morphine	Codeine	6-AM	Oxycodone	Hydrocodone
Range in concentration pg/mg
hair (Before)	520 - 1690	480 - 1150	600 - 2140	157 - 5174	196 - 2524
Range in concentration pg/mg
hair (After)	530 - 1588	539 - 1132	636 - 1987	156 - 4638	207 - 2359
Mean Change	1%	7%	4%	-4%	-5%
% Max and Min Decrease	--20% and -3%	--2%	-8% and -7%	-16% and -1%	-23% and -1%

Table 6:Storage Stability Study Data Summary Ranges

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Study Observation	Morphine	Codeine	6-AM	Oxycodone	Hydrocodone
% Max and Min Increase	35% and 1%	18% and 1%	16% and 1%	15% and 3%	6% and 5%
Number that increased in
concentration	5	8	5	4	3
Number that decreased in
concentration	7	2	2	8	10

Table 6:Storage Stability Study Data Summary Ranges

Based on the data presented, opiates are stable in hair for 3 years and oxycodone and hydrocodone are stable for 2 year.

SHIPPING:

260 head hair samples were used in the shipping study; 155 samples previously confirmed positive, 100 previously screened negative samples and 5 samples that were confirmed below the 300 pg/mg cutoff. Each box contained a variety of hair color and curvature.

The minimum and maximum shipping temperature and humidity ranges are shown in the tables for the Negative samples and for the Positive samples below. Negative samples were shipped separate from the Positive samples.

| DataLogger ID | Shipped to Location Then
Returned to Omega
Laboratories | Min Temp
(°C) | Max Temp (ºC) | Min Humidity
(%RH) | Max Humidity
(%RH) |
|---------------|---------------------------------------------------------------|------------------|---------------|-----------------------|-----------------------|
| 7310005629 | 1. Portland, Maine | -12.7 | 44.4 | 10.8 | 100 |
| 7310005644 | 2. Anchorage, Alaska | -9.4 | 44.9 | 8.1 | 96.1 |
| 7310005628 | 3. Naples, Florida | -10.8 | 43.3 | 4.4 | 100 |
| 7310005627 | 4. Tempe Arizona | -12.2 | 42.9 | 8.9 | 73.5 |

Table 7a: Negative Samples Shipping Temperatures and Humidity Ranges Negative Samples

Table 7b: Positive Samples Shipping Temperatures and Humidity Ranges Positive Samples

| DataLogger ID | Shipped to Location Then
Returned to Omega
Laboratories | Min Temp
(°C) | Max Temp (°C) | Min Humidity
(%RH) | Max Humidity
(%RH) |
|---------------|---------------------------------------------------------------|------------------|---------------|-----------------------|-----------------------|
| 7310005629 | 1. Portland, Maine | -12.8 | 50.8 | 0 | 97.8 |
| 7310005644 | 2. Anchorage, Alaska | -13.8 | 47.6 | 0 | 100 |
| 7310005628 | 3. Naples, Florida | -11.6 | 51.3 | 0 | 100 |
| 7310005627 | 4. Tempe Arizona | -15.3 | 41.9 | 3.2 | 100 |

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The Shipping Study demonstrated that there is no adverse effect on hair samples that would affect the screening assay when samples are exposed to extreme temperatures and variations in humidity that might occur during sample transport. The average mean % of change in screening result prior to shipping and after shipping was 1.9% for all locations combined. Four samples out of 260 had screening results that were different prior to and after shipping. All of these samples were within ±50% (150-450 pg/mg) of the cutoff level where variances in a qualitative screening assay are to be expected.

COSMETIC TREATMENT:

Numerous studies have demonstrated that the use of cosmetic treatments can reduce the amount of drugs and metabolites detected in hair specimens. This effect is completely dependent upon the nature of the hair specimen and the treatment used, and is independent of the method of analysis. This study demonstrates that the Omega Laboratories, Inc. ELISA Opiates Screening Protocol is not an exception to this phenomenon.

Test conditions:

. BLEACH #1 - Salon Care Blue Flash Professional Powder Lightener BLEACH #2 - Loreal Super Oreal Blanc® Professional Powder Bleach
. PERM #1 - Naturelle Natural Curls Alkiline Perm PERM #2 - Natural Apple Self-Timing Perm
. DYE #1 - Revlon® Colorsilk™ Black DYE #2 - Garnier Herbashine Soft Mahogany Dark Brown
. RELAXER #1 - Silk Elements™ No-Lye Sensitive Scalp Relaxer System RELAXER #2 - Ultra Precise No-Lye Conditioning Relaxer
. SHAMPOO #1 - After Burner drug removing shampoo SHAMPOO #2 - Ultra Cleanse drug removing shampoo

176 hair samples were used in this study. Of the 176 hair specimens were identified as positive in the untreated Run No. 1 for opiates and/or oxycodone by ELISA assays and 64 specimens were identified as negative by ELISA assay. The ethnic origin, hair color and curvature were documented.

Each specimen was divided into 2 aliquots. One aliquot was analyzed by the ELISA protocol and the GC/MS confirmation method

The second aliquots were randomly assigned to the hair treatments listed above and the treatments were performed following the product insert.

Treated aliquots were analyzed by the ELISA protocol as summarized and the GC/MS confirmation method.

| Treatment | Opiates | Oxycodone/
Hydrocodone | Comment |
|-----------|-------------------------------|---------------------------|-----------------------------------|
| Bleach | None | None | NA |
| Dye | Pos⇒Neg (57)
Neg⇒Pos (110) | None | Change at cutoff |
| Permanent | Neg⇒Pos (29)* | None | Change due to cross
reactivity |

Table 8: Changes in ELISA Assay Test Results after Cosmetic Treatment (Pos ⇒ Nea or Nea ⇒ Pos)

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| Treatment | Opiates | Oxycodone/
Hydrocodone | Comment |
|-----------|---------|------------------------------|------------------|
| Relaxer | None | None | NA |
| Shampoo | None | Pos→Neg (89)
Pos→Neg (65) | Change at cutoff |

Table 8: Changes in ELISA Assay Test Results after Cosmetic Treatment (Pos ⇒ Neg or Neg ⇒ Pos)

*Cross-reactive at 0.24 for HDC to Opiates

There was no single treatment that had a more defined effect on the assay. The single largest change was observed in the relaxer for oxycodone at -34.8%. Bleach treatment appeared to have the consistent result across all drugs. All of the treatment appeared to have the greatest change on oxycodone. See Table 9 for summary of treatment percent change review.

| Treatment | Opiates Mean change in
concentration (pg/mg) | OXY Mean change in
concentration (pg/mg) | HCD Mean change in
concentration
(pg/mg) |
|-----------|-------------------------------------------------|---------------------------------------------|------------------------------------------------|
| Bleach | -10.4% | -15% | -10% |
| Permanent | -7.5 | -14.5 | -13.6 |
| Dyeing | -7.5% | -18.3% | -15.6% |
| Relaxer | -2% | -34.8% | -7% |
| Shampoo | -1.4% | -17.8% | -3.4% |

Table 9: Summary GC/MS data for Cosmetic Studies

ENVIRONMENTAL CONTAMINATION:

Two studies were performed to investigate whether confirmatory testing procedures are able to distinguish between true analytically positive samples and those that have been externally exposed to Opiates, Oxycodone and Hydrocodone. The focus of the studies was to demonstrate that a methanol wash procedure mitigates the risk of false positive results while maintaining true analytical positive results.

The first study involved exposing drug-free hair to Opiates, Oxycodone and Hydrocodone, washing the hair with methanol three times, performing confirmation testing on the samples and the washes, and observing the final test result. The second study involved performing confirmation testing on known positive samples and observing whether the methanol washes change the final result. Head hair was used for this study.

Evaluating potential environmental contamination and the effectiveness of a methanol wash using this study design, all analytically negative samples tested remained negative after being subjected to Opiates, Oxycodone and Hydrocodone by the exposure modes described followed by a single methanol wash.

Additionally, all clinically positive samples tested remain positive after the wash steps were performed.

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SUMMARY CONCLUSION:

The comparison of results of the proposed assay with the confirmatory GC/MS testing of head and body hair samples showed the results to be substantially equivalent

The candidate Omega Hair Drug Screening Assay for Opiates, Oxycodone and Hydrocodone (head and body hair) is substantially equivalent to the predicate Omega Hair Drug Screening Assay for Opiates, Oxycodone and Hydrocodone (K103161 for head hair) based on the design and performance studies discussed in this summary. Supporting Performance Testing presented for review in this document, includes agreement, precision, specificity, interference (including cosmetic effects), removal of environmental contamination, stability and shipping tests.